Blood levels of homocysteine are elevated in Alzheimer's disease (AD), and hyperhomocysteinemia may contribute to disease pathophysiology by vascular and direct neurotoxic mechanisms. Homocysteine levels can be reduced by administration of high dose supplements of folic acid and vitamins B6 and B12. The ADCS proposes a multicenter, randomized, controlled clinical trial to determine whether reduction of homocysteine levels with high-dose folic acid/B6/B12 supplementation will slow the rate of cognitive decline in subjects with AD.

What is the main objective of this study?

The main objective of this study is to determine whether reduction of homocysteine levels with high-dose folic acid, B6, and B12 supplementation will slow the rate of cognitive decline in subjects with AD

What are the secondary objectives of this study?

The other objectives of this study are:

Determine whether reduction of homocysteine levels with high-dose folic acid/B6/B12 supplementation will slow the rate of clinical decline, as measured by the time to reach clinically significant end-points, in subjects with AD

Determine whether reduction of homocysteine levels with high-dose folic acid/B6/B12 supplementation will favorably influence measures of behavior, activities of daily living, global status, and quality of life in subjects with AD

Examine the influence of apolipoprotein E and methylenetetrahydrofolate reductase (MTHFR) genotype on homocysteine reduction in subjects with AD

Determine the safety and tolerability of long-term treatment of AD subjects with high-dose supplements

How will this study be conducted?

This is a parallel design, randomized controlled trial, with two groups of unequal size: 60% of subjects will receive daily high-dose supplements, and 40% will receive identical placebo. The study duration is 18 months.

How many patients will be participating in this study?

A total of 400 patients will be recruited for the study with 15 patients from USC.

How can I enroll in this study?

This study is currently enrolling volunteers. If interested, please contact:Randall Sanabria, Margaret Villa, R.N. University of Southern California Keck School of Medicine (323) 442-7600 e-mail: randalls@usc.edu